DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease

Launched by IRCCS ISTITUTO DELLE SCIENZE NEUROLOGICHE DI BOLOGNA · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different treatment approaches—adjusting the stimulation from a device in the brain (known as deep brain stimulation or DBS) and increasing the dose of a medication called levodopa—can help improve a specific symptom called freezing of gait (FoG) in people with Parkinson's disease. FoG can make it hard for patients to walk and can lead to falls, impacting their daily lives and independence. The researchers want to find out which approach, or if a combination of both, is more effective in helping patients with FoG.

To participate in this study, individuals must be between 65 and 74 years old and have Parkinson's disease with a history of FoG that occurs even when their DBS is working well. They should be able to manage their movement symptoms, but not everyone will qualify. For instance, those who can't walk independently for 10 meters or who have experienced severe side effects from high doses of levodopa or increased DBS intensity will be excluded. Participants will have the chance to receive closer monitoring and adjustments to their treatment, which could lead to improvements in their walking and overall quality of life. This trial is currently recruiting participants, and anyone interested should discuss it with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor)
• • History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire.
• Exclusion Criteria:
• • inability to walk independently for 10 meters.
• • limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects
• • previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms.
• • dementia (MMSE score ≤ 18)